Tidl Pain Relief Cryo Therapy Limited Edition

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those related to arthritis, simple backache, strains, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate course of action and dosage.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used while smoking or near heat or open flame due to the risk of fire.

Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Application to wounds, damaged skin, or irritated skin is contraindicated as it may exacerbate the condition. Additionally, the product should not be bandaged or used in conjunction with heating pads or devices, as this may lead to increased absorption and potential adverse effects. When applying the product, it is essential to spray it away from the nose, eyes, and mouth to minimize the risk of accidental exposure.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin. Additionally, it is advised not to bandage the area after application. Healthcare professionals should instruct patients to wash their hands thoroughly with cool water after use and to refrain from using the product in conjunction with heating pads or devices. When applying the spray, it should be directed away from the nose, eyes, and mouth to prevent accidental exposure.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Patients should be advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days.

Side Effects

For external use only. Patients should discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. In such cases, it is advisable for patients to consult a healthcare professional.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as this may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine laboratory monitoring is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Tidl Pain Relief Cryo Therapy Limited Edition (pain relief cryo therapy limited edition). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of TIDL PAIN RELIEF CRYO THERAPY LIMITED EDITION during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this product to women of childbearing potential. Further studies may be necessary to determine the effects on fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the overdose, is crucial for ongoing patient management and for informing any necessary follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to emphasize the necessity of turning the child safety spray lock to the off position when the product is not in use to prevent accidental exposure.

Patients should be instructed to avoid contact with the eyes and mucous membranes, as this could lead to irritation or injury. Additionally, they should not apply the product to wounds, damaged skin, or any areas of irritated skin to prevent adverse reactions. Healthcare providers should inform patients that the product should not be bandaged after application.

Patients are encouraged to wash their hands thoroughly with cool water after using the product to ensure that any residue is removed. It is also crucial to advise against the use of the product in conjunction with heating pads or devices, as this may lead to unintended effects. Lastly, patients should be reminded to spray the product away from the nose, eyes, and mouth to minimize the risk of exposure to sensitive areas.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the container from light and ensure that it remains tightly closed when not in use. Freezing the product is not permitted, as it may compromise its integrity. Additionally, the product should be kept out of reach of children to ensure safety. When the product is not in use, it is important to turn the child safety spray lock to the off position to prevent accidental discharge.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tidl Pain Relief Cryo Therapy Limited Edition, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)